Date: 2015-01-28
Type of information: Production agreement
Compound: aramchol
Company: Galmed Pharmaceuticals (Israel) Perrigo (Ireland)
Therapeutic area: Hepatic diseases - Liver diseases
Type agreement: manufactuiring - production
Action mechanism: bile-acid conjugate. Aramchol is a conjugate of cholic acid and arachidic acid. This is a first in class member of a novel family of synthetic Fatty-Acid / Bile-Acid Conjugates (FABACs). FABACs are composed of endogenic compounds, orally administrated with potentially good safety and tolerability parameters. Aramchol affects liver fat metabolism and has been shown in a phase IIa clinical study to significantly reduce liver fat content as well as improve metabolic parameters associated with fatty liver disease.
Disease: NASH (non-alcoholic steatohepatitis)
Details:
- • On January 28, 2015, Galmed Pharmaceuticals announced that it has entered into a manufacturing services agreement with Perrigo API, a subsidiary of Perrigo, for the large-scale production of the active pharmaceutical ingredient (API) of Galmed's product candidate, aramchol. The API produced pursuant to this agreement is expected to provide sufficient quantities of aramchol for Galmed's potential future Phase III clinical trials of aramchol for the treatment of non-alcoholic steato-hepatitis.
- According to the terms of the agreement, Perrigo will provide manufacturing process optimization services for large-scale production of the aramchol API, manufacture the aramchol API pursuant to current good manufacturing processes, or cGMP, and perform additional development services regarding scale-up and manufacturing optimization for the aramchol API. The agreement also provides Perrigo with the option to manufacture commercial supplies of the aramchol API in the future.
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